Duphaston
In brief
- In many countries Duphaston (dydrogesterone) is officially prescription-only (Rx), but availability varies by jurisdiction and pharmacy — in some areas and through some pharmacies or online suppliers it may be possible to purchase duphaston without a prescription; check local regulations and pharmacy policies.
- Duphaston is a synthetic progestogen used for luteal phase support in infertility, prevention of threatened and habitual miscarriage, secondary amenorrhea, dysfunctional uterine bleeding, endometriosis, dysmenorrhea/PMS and as part of HRT; it acts as a selective progesterone receptor agonist, stabilizing the endometrium and supporting progesterone-dependent processes while lacking significant androgenic, estrogenic or glucocorticoid effects.
- Usual dosages vary by indication but typical regimens include 10 mg once daily for luteal support or HRT, 10 mg twice daily for secondary amenorrhea or dysfunctional bleeding, 10–20 mg daily for endometriosis, an initial 40 mg followed by 10 mg every 8 hours for threatened abortion, and 10 mg daily through at least week 20 for habitual abortion — follow prescriber guidance.
- Form of administration: oral tablet (10 mg tablets, usually in blister packs of 20).
- Onset time: the drug is absorbed within about 1–3 hours after oral dosing; measurable clinical effects on the endometrium or bleeding patterns are usually seen within days of starting treatment.
- Duration of action: clinical effects are maintained with daily dosing (typically considered to provide coverage over a 24-hour period); overall treatment duration depends on the indication (from single cycles up to months or through gestation for miscarriage prevention).
- Alcohol warning: avoid excessive alcohol while taking duphaston — alcohol may worsen side effects (dizziness, fatigue) and heavy drinking should be avoided, especially in people with liver disease; duphaston is not recommended in severe hepatic impairment.
- Most common side effec: breast pain or breast tenderness.
- Would you like to try duphaston without a prescription?
Basic Duphaston Information
- INN (International Nonproprietary Name): Dydrogesterone.
- Brand Names Available In Canada (English): Duphaston — blisters of 20 tablets, 10 mg each; Duphaston is marketed in many countries including most European countries (excluding the UK), Russia, CIS and multiple Asian markets, and supplied as 10 mg oral tablets in carton boxes or clinic packs.
- ATC Code: G03DB01 — G03: Sex hormones and modulators of the genital system; D: Progestogens; B: Progestogens, plain; 01: Dydrogesterone specifically.
- Forms & Dosages: Tablet, 10 mg strength, usually supplied in blisters of 20 tablets; currently available only as oral tablets and no injectable, cream, or vaginal forms are marketed.
- Manufacturers In Canada (English): Primary global supplier and MAH is Laboratoires Abbott Products (Abbott/AbbVie); local manufacturing or licensing varies by country and no generic dydrogesterone with large international penetration is specified.
- Registration Status In Canada (English): Registered in most European countries (except UK), Russia and multiple Asian markets; not available in the USA (withdrawn) and not available in the UK (withdrawn); Canadian registration is not specified in the provided data and should be checked on the Health Canada Drug Product Database.
- OTC / Rx Classification: Prescription-only (Rx) in all countries where it is marketed; not available over-the-counter (OTC).
Critical Warnings And Restrictions In Canada
Safety-First Summary For Canadian Patients
Before buying or taking duphaston, confirm you have a prescription from a licensed Canadian prescriber.
Verify product authenticity by buying from a regulated Canadian pharmacy and check Health Canada Drug Product Database for Marketing Authorisation and a Drug Identification Number (DIN) before purchase.
INN: dydrogesterone, marketed internationally as Duphaston in 10 mg oral tablets only.
Contraindications To Prioritise:
- Known allergy to dydrogesterone.
- Suspected or proven progestogen-dependent tumours.
- Active or severe liver disease.
- Undiagnosed vaginal bleeding.
Monitor And Report: new severe headaches, any visual disturbances, chest pain, or leg swelling require emergency assessment and reporting of adverse events to Health Canada’s Canada Vigilance Program.
High-Risk Groups
Elderly: data are limited and use requires close review of comorbidities and polypharmacy risks.
Pregnant Patients: dydrogesterone is used in some protocols for habitual and threatened abortion internationally, but follow obstetrical guidance closely.
Indigenous Health Considerations: provide culturally safe counselling, and liaise with Indigenous health services to ensure accessible care and follow-up where required.
Q&A — “Can I Drive After Taking It In Canada?”
Most people are unaffected and can drive normally after taking duphaston.
If dizziness, drowsiness, blurred vision or mood changes occur, do not drive or operate machinery until symptoms resolve.
Employers and people in safety-sensitive work must follow provincial occupational health rules regarding fitness for duty and medication use.
Usage Basics For Canadians
INN, Brand Names, And Availability In Canada
INN: dydrogesterone, most commonly known internationally as Duphaston in 10 mg tablets packaged in blisters of 20 tablets.
Duphaston has been discontinued in the UK and USA and Canadian market presence is not specified in the provided data.
Always check the Health Canada Drug Product Database to confirm current authorisation and any DIN before ordering or dispensing.
Legal Classification Under Health Canada
Progestogens such as dydrogesterone are generally prescription-only in Canada and should be treated as Rx until local confirmation is available.
Checklist: verify DIN, confirm the Marketing Authorisation Holder (MAH), and review the approved product label and monograph for intended indications.
Where To Verify
- Search the Health Canada Drug Product Database by active ingredient (dydrogesterone) or brand (Duphaston).
- Contact your provincial regulatory body or local pharmacist to confirm DIN and coverage under provincial formularies such as Ontario Drug Benefit, BC PharmaCare or RAMQ.
- Ask the pharmacist to confirm tablet strength (10 mg) and bilingual labelling where applicable in your province.
Canadian Dosing Guide
Standard Regimens (Practical Guide)
Secondary amenorrhea: 10 mg twice daily, commonly given on cycle days 11–25 or as directed.
Luteal support and infertility: typically 10 mg once daily on days 14–25 of the cycle or continued as per fertility protocol.
Dysfunctional uterine bleeding: 10 mg twice daily for 5–7 days is commonly used.
Threatened abortion protocols may start with an initial higher loading (for example, an initial 40 mg followed by 10 mg every 8 hours) then maintenance dosing; follow prescriber instructions.
Tablet form only: 10 mg oral tablets are the only marketed form.
Adjustments And Comorbidities
Hepatic Impairment: avoid in severe liver disease due to hepatic metabolism.
Elderly: no established dosing recommendations; use with usual progestogen precautions.
Caution with diabetes, hypertension or thromboembolic history; monitor clinically and adjust therapy if needed.
Q&A — “What If I Miss A Dose Under My Provincial Drug Plan?”
Clinical missed-dose advice: take as soon as remembered unless it is almost time for the next dose; do not double the dose.
Coverage note: provincial drug plans do not change dosing rules; if you risk running out contact your pharmacist or your provincial drug program for early refill or exception processes.
Interaction Chart (Canadian Context)
Food, Drink And Lifestyle Interactions
- No major food interactions are documented for dydrogesterone.
- Alcohol can worsen drowsiness or mood changes and should be limited when starting therapy.
- Excessive caffeine may worsen anxiety or sleep disturbance while adjusting to treatment.
Common Drug Interactions And Monitoring
| Interacting Drug | Effect | Monitoring / Action |
|---|---|---|
| Rifampicin, Carbamazepine, Phenytoin | Hepatic enzyme induction may lower dydrogesterone levels | Monitor clinical response and consider dose adjustment or alternative therapy |
| Other Progestogens / HRT | Overlapping progestogenic effects | Review regimen with prescriber to avoid duplication |
| Anticoagulants | Progestogens can alter coagulation parameters indirectly | Monitor INR or clotting as per anticoagulant protocol |
| Antidiabetics | Potential metabolic interactions affecting glucose control | Monitor blood glucose and adjust antidiabetic therapy if needed |
Workplace And Driving Safety
If treated for mood disorders or on sedating medications, coordinate with workplace safety officers about fitness for duty.
Pharmacist Counselling Prompt: provide a one-page interaction summary when patients are on multiple medications to support safe use and employer discussions.
User Reports And Trends In Canada
Where Canadian Patients Report Experiences
Patient feedback is commonly posted on provincial patient forums, national review sites, reproductive health clinic feedback forms, and pharmacy counselling records.
Duphaston may have limited presence in Canada and many Canadian patients instead report experiences with alternatives such as micronized progesterone, medroxyprogesterone, and norethisterone.
Typical Patient-Reported Themes
- Reports of efficacy for luteal support and in miscarriage prevention protocols.
- Fewer androgenic side effects compared with some older synthetic progestins.
- Commonly reported mild effects include breast tenderness, headache and spotting.
How Pharmacists Collect Data
Recommend routine follow-up at 2–4 weeks after initiation and document adverse reactions in provincial reporting systems.
Consider anonymized patient surveys in clinics to capture tolerability and adherence information.
Community Pharmacy Feedback Process Checklist:
- Record baseline indication and start date.
- Schedule a 2–4 week follow-up contact.
- Log adverse events and report to Canada Vigilance as appropriate.
Access And Purchase Options
Where Canadians Can Obtain Prescription Progestogens
- Regulated community pharmacies such as Shoppers Drug Mart, Rexall, London Drugs and Jean Coutu, and hospital pharmacies.
- Special-order or import processes may be required if dydrogesterone (Duphaston) is not marketed in Canada.
Online Pharmacies And Provincial Restrictions
Only use licensed Canadian online pharmacies and verify the product label lists a DIN and MAH where available.
Imported products fall under Health Canada guidance and personal importation rules vary; imported medications risk being unlicensed and require careful review.
Practical Steps To Obtain Treatment
- Obtain a valid prescription from a licensed prescriber.
- Ask a pharmacist to check the Health Canada Drug Product Database for DIN and MAH.
- Confirm provincial formulary coverage or request prior authorization if required.
- If the product is unlicensed in Canada, discuss importation risks and institutional approval.
Tip: keep a paper or electronic copy of the prescription for reimbursement and safety checks.
Purchase Context: In our online pharmacy, duphaston is available without a prescription, with discreet delivery to Canada (English) in 5-14 days.
Mechanism And Pharmacology
Patient-Friendly Explanation
Dydrogesterone is a synthetic oral progestogen that mimics many of natural progesterone’s effects on the endometrium and luteal support.
It has little or no androgenic, estrogenic or glucocorticoid activity compared with some older progestins.
Clinical Pharmacology Highlights
ATC: G03DB01 — progestogens, plain, with dydrogesterone as the specific substance.
Oral absorption with hepatic metabolism; only oral tablets are marketed (10 mg).
Relevance To Patients
Dydrogesterone is used to induce withdrawal bleeding, to support early pregnancy in certain protocols, and to stabilise the endometrium in cycle-related symptoms.
Suggested Patient Handout Diagram: simple timeline showing luteal support days and expected effects on the endometrium can aid adherence and understanding.
Indications And Off-Label Uses In Canada
Approved And Commonly Used Indications
International indications include secondary amenorrhea, luteal phase deficiency/infertility support, dysfunctional uterine bleeding, threatened and habitual abortion, endometriosis, PMS/dysmenorrhea and as an adjunct in HRT with estrogen.
Canadian Context And Off-Label Practice
If dydrogesterone is not marketed in Canada, clinicians commonly use alternatives with approved DINs such as micronized progesterone (Prometrium), medroxyprogesterone acetate (Provera) or norethisterone.
| Indication | Typical International Regimen | Canadian Alternative With DIN |
|---|---|---|
| Secondary Amenorrhea | 10 mg twice daily, days 11–25 | Norethisterone or medroxyprogesterone acetate |
| Luteal Support/Infertility | 10 mg daily, days 14–25 or continuous | Micronized progesterone (oral or vaginal) such as Prometrium |
| Threatened/Habitual Abortion | Initial dosing can be higher then maintenance to 10 mg daily | Consider micrionized progesterone or other progestogens per obstetric protocol |
Documentation And Consent
For off-label or imported use, document the clinical rationale, discuss risks and obtain informed consent.
Report adverse events to Health Canada when using imported or special-access products.
Key Clinical Findings
Recent Evidence Summary (2022–2025)
Dydrogesterone has a long clinical history since 1961 and continues to be used in infertility and miscarriage prevention protocols internationally.
Recent literature trends suggest efficacy for luteal support with a favourable tolerability profile compared with some other progestins.
Clinicians should perform a local literature search for Canadian or regional studies published between 2022 and 2025 for the latest evidence.
Safety Monitoring In Canada
Monitor for thromboembolic events, mood changes and liver function in at‑risk patients.
Report any suspected adverse reactions to Health Canada’s Canada Vigilance Program.
Suggested Evidence Table
Create a compact evidence table for clinic use with columns: study (year), population, intervention, outcome and safety signal.
Include Canadian or regional data where available and flag gaps for further research and local audits.
Alternatives Matrix
Comparable Medicines With DIN In Canada (Practical)
| Molecule | Form | ATC Class | Primary Use | Pros / Cons |
|---|---|---|---|---|
| Micronized Progesterone (Prometrium) | Oral, vaginal | G03DA04 | HRT, infertility | Pros: natural progesterone profile; Cons: variable oral absorption |
| Medroxyprogesterone Acetate (Provera) | Oral, injectable | G03AC06 | Amenorrhea, bleeding | Pros: widely available; Cons: different side-effect profile |
| Norethisterone | Oral | G03AC01 | Endometriosis, HRT | Pros: effective for bleeding; Cons: some androgenic activity |
Pros And Cons Checklist
- Compare androgenic activity and metabolic profile.
- Consider route of administration preference: oral versus vaginal options.
- Review pregnancy safety data when fertility is the goal.
- Factor in HRT compatibility, cost and formulary coverage.
Decision Support For Prescribers
Base choice on patient-centred factors such as fertility goals, comorbidities, route preference and provincial coverage.
Document the clinical rationale when selecting an alternative or when seeking imported dydrogesterone for a patient.
Common Questions From Canadian Patients
- How long until it works? Typically a few days to weeks for bleeding regulation; luteal support effects on the endometrium occur immediately but are assessed by cycle outcomes.
- Will it affect my fertility? At standard doses it does not inhibit ovulation and is commonly used for luteal support in fertility treatments.
- Is it safe in pregnancy? It is used in certain miscarriage prevention protocols internationally; follow obstetric guidance and monitoring.
- Can I take other hormone therapies? Coordinate with the prescriber since interactions and duplicate progestogen exposure are possible.
- Where to report side effects? Contact your prescriber and local pharmacist, and report to Health Canada via the Canada Vigilance Program.
Coverage And Purchase Comparison Table
Province / Plan Coverage Snapshot
| Province / Plan | Coverage Status | Typical Patient Cost | Prescription Requirement | Notes On Prior Auth |
|---|---|---|---|---|
| Ontario Drug Benefit (ODB) | Not Specified — verify DIN | Varies | Prescription required | Prior authorization possible if product is special-order |
| BC PharmaCare | Not Specified — verify DIN | Varies | Prescription required | Check special authority rules |
| RAMQ (Quebec) | Not Specified — verify DIN | Varies | Prescription required | Institutional approval may be needed for imported products |
| Private Insurers | Conditional | Depends on plan | Prescription required | Reimbursement requires DIN and product listing |
Step-By-Step Purchase Checklist For Canadian Patients
- Obtain a prescription from a licensed prescriber.
- Ask a pharmacist to check the Health Canada Drug Product Database and confirm a DIN and MAH.
- Verify provincial formulary coverage or submit an exception or prior authorization request.
- If the product is unlicensed in Canada, discuss importation risks and institutional approval with the prescriber and pharmacist.
Pharmacy Tips
Keep receipts and verify bilingual labelling in provinces where required.
Request counselling documentation to support reimbursement claims and to ensure safe use.
Registration And Regulation
Health Canada Approval Process — What To Check
Before recommending or dispensing, confirm Marketing Authorisation Holder (MAH), Drug Identification Number (DIN), approved monograph/label and packaging compliance.
If a product lacks Canadian authorisation, use licensed alternatives or follow special-access and import procedures per institutional policy.
Labelling And Language Requirements
Ensure bilingual labelling where applicable in Canada and check lot numbers and storage instructions on receipt.
Storage guidance for the product: store below 30°C and protect from moisture and heat.
Reporting And Pharmacovigilance
Report adverse events to Canada Vigilance and include supplier, batch and expiry details for imported or special-access products.
Definition List:
- DIN: Drug Identification Number assigned by Health Canada.
- MAH: Marketing Authorisation Holder, the company responsible for the product.
- Special Access: pathways for unlicensed medicines where clinical need is documented and approved.
Storage And Handling
Household And Pharmacy Storage
Store oral tablets below 30°C and protect from moisture and heat.
Keep tablets in the original blister until use and avoid storing in bathrooms or near heat sources.
Transport And Clinic Handling
Follow standard precautions for solid oral medication transport and avoid prolonged heat exposure or humidity during shipping.
Handling Checklist For Travel Or Mail-Order Shipment:
- Keep blister packs in a protective container.
- Avoid direct sunlight and high-temperature exposure during transit.
- Confirm courier handling procedures for medications.
Disposal
Return unused or expired tablets to pharmacy take-back programs; do not flush them down the toilet.
Hospital settings should follow local medication waste and disposal protocols and maintain batch records and counselling leaflets for patients.
Guidelines For Proper Use
Pharmacist Counselling Script (Practical Points)
Confirm the indication, the dosing regimen and duration and that the product is the 10 mg tablet form.
Explain missed-dose advice: take as soon as remembered unless close to the next dose; do not double the dose.
Describe common side effects: breast tenderness, headache, nausea and spotting, and list absolute contraindications such as active liver disease and allergy to dydrogesterone.
Provincial Authority Recommendations
Follow provincial reproductive health guidelines, fertility clinic protocols and formulary rules.
Document informed consent for off-label or imported use and record the clinical rationale in the patient chart.
Follow-Up And Monitoring Checklist
- Baseline assessment: liver function where indicated, thromboembolic risk, mood history and pregnancy status.
- Schedule follow-up contact at 2–4 weeks after initiation and then as clinically indicated.
- Report adverse events to Health Canada and maintain documentation of supplier and batch data for imported products.
Delivery Across Canada (English)
| City | Region | Delivery Time |
|---|---|---|
| Toronto | Ontario | 5-7 days |
| Montreal | Quebec | 5-7 days |
| Vancouver | British Columbia | 5-7 days |
| Calgary | Alberta | 5-7 days |
| Edmonton | Alberta | 5-7 days |
| Ottawa | Ontario | 5-7 days |
| Winnipeg | Manitoba | 5-7 days |
| Quebec City | Quebec | 5-7 days |
| Hamilton | Ontario | 5-9 days |
| Halifax | Nova Scotia | 5-9 days |
| Victoria | British Columbia | 5-9 days |
| Saskatoon | Saskatchewan | 5-9 days |
| Regina | Saskatchewan | 5-9 days |
| London | Ontario | 5-9 days |
